BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOIN

    MDR report key: 23606258 · Received November 20, 2025

    Report

    Report Number
    MW5179176
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 11, 2025
    Report Date
    November 17, 2025
    Manufacturer
    VALENCIA TECHNOLOGIES CORPORATION
    Product Code
    QPT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REP REPORTED THEY SPOKE WITH DR. (B)(6) ABOUT THIS CASE AND DR. (B)(6) SAID THAT THEY WERE SURE THIS WAS A CASE OF ALLERGIC REACTION AND NOT INFECTION. REP ALSO NOTED THAT ALTHOUGH THEY¿RE SAYING IT¿S A SILICONE ALLERGY, REP BELIEVES IT COULD BE TITANIUM, OR METAL. REP SAID A COUPLE OF HCPS INCLUDING DR. (B)(6) NOTED THAT THEY SAW SIMILAR ALLERGIC REACTIONS WITH THE ECOIN TRIAL, SO REP THINKS IT COULD BE THE METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077000 ECOIN STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE QPT VALENCIA TECHNOLOGIES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown